Keryx Biopharmaceuticals Announces Submission of a Marketing Authorization Application for Zerenex(TM) to the European Medici...
March 10 2014 - 8:30AM
Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) (the "Company") today
announced it has submitted a Marketing Authorization Application
("MAA") to the European Medicines Agency ("EMA"), seeking the
approval of Zerenex™ (ferric citrate coordination complex) as a
treatment for hyperphosphatemia in patients with chronic kidney
disease ("CKD"), including dialysis- and non-dialysis dependent
CKD.
The MAA will be reviewed by the EMA Committee for Medicinal
Products for Human Use (CHMP) and the review will be conducted
under the Centralized Authorization Procedure. An approval under
the Centralized Authorization Procedure provides one marketing
authorization which is valid in all 27 member states of the
European Union, as well as in Norway, Liechtenstein and
Iceland.
Ron Bentsur, Chief Executive Officer of Keryx, commented, "We
are pleased to have submitted our MAA, seeking European approval of
Zerenex for both dialysis and pre-dialysis and believe that this
marks another important milestone for Keryx. We thank the EMA for
their guidance and look forward to working with them over the
course of the review process."
The Company's new drug application for Zerenex is currently
under review by the FDA with an assigned Prescription Drug User Fee
Act (PDUFA) goal date of June 7, 2014. In January, it was announced
that the Company's Japanese partner, Japan Tobacco, Inc. and Torii
Pharmaceutical Co., Ltd. ("JT/Torii"), received marketing approval
of ferric citrate (branded Riona®) in Japan for the improvement of
hyperphosphatemia in patients with CKD, including dialysis and
non-dialysis dependent CKD.
Keryx Biopharmaceuticals retains a worldwide exclusive license
(except for the Asian Pacific Region) to Zerenex from Panion &
BF Biotech, Inc. The Company has sublicensed the development of
ferric citrate in Japan to JT/Torii.
About Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals focuses on the acquisition, development
and commercialization of pharmaceutical products for the treatment
of renal disease. Keryx is developing Zerenex (ferric citrate
coordination complex), an oral, ferric iron-based compound. Keryx
has completed a U.S.-based Phase 3 clinical program for Zerenex for
the treatment of hyperphosphatemia (elevated phosphate levels) in
patients with chronic kidney disease (CKD) on dialysis, conducted
pursuant to a Special Protocol Assessment (SPA) agreement with the
Food and Drug Administration (FDA). The Company's New Drug
Application (NDA) is currently under review by the FDA with an
assigned Prescription Drug User Fee Act (PDUFA) goal date of June
7, 2014. The Company's Marketing Authorization Application, seeking
the approval of Zerenex as a treatment of hyperphosphatemia in
patients with CKD, including dialysis and non-dialysis dependent
CKD, has been submitted to the European Medicines Agency (EMA). The
Company is also developing Zerenex in the U.S. for the management
of elevated serum phosphorus and iron deficiency anemia in patients
with Stage 3 to 5 non-dialysis dependent CKD. In addition, Keryx's
Japanese partner, Japan Tobacco Inc. and Torii Pharmaceutical Co.,
Ltd. has received marketing approval of ferric citrate (branded
Riona®) in Japan for the improvement of hyperphosphatemia in
patients with CKD, including dialysis and non-dialysis dependent
CKD. Keryx is headquartered in New York City.
Cautionary Statement
Some of the statements included in this press release,
particularly those relating to the results of clinical trials, the
clinical benefits to be derived from Zerenex, regulatory
submissions and approvals, the commercial opportunity and
competitive positioning, and any business prospects for Zerenex,
may be forward-looking statements that involve a number of risks
and uncertainties. For those statements, we claim the protection of
the safe harbor for forward-looking statements contained in the
Private Securities Litigation Reform Act of 1995. Among the factors
that could cause our actual results to differ materially are the
following: the risk that the MAA submission will not be accepted
for review by the EMA due to deficiencies in the application or for
other reasons; acceptance of the NDA filing for review by the FDA,
which occurred in October 2013, represents only a preliminary
evaluation of the application and is not indicative of deficiencies
that may be identified during the FDA's review; a PDUFA goal date
is subject to change and does not guarantee that the review of the
NDA will be completed on a timely basis; the risk that the FDA,
and/or EMA ultimately deny approval of the U.S. NDA, and/or MAA,
respectively; the risk that SPAs are not a guarantee that the FDA
will ultimately approve a product candidate following filing
acceptance; whether the FDA and EMA will concur with our
interpretation of our Phase 3 study results, supportive data, or
the conduct of the studies; whether Riona® will be successfully
launched and marketed by our Japanese partner, Japan Tobacco, Inc.
and Torii Pharmaceutical Co., Ltd.; whether, Zerenex, if approved
by the FDA and/or EMA, will be successfully launched and marketed;
and other risk factors identified from time to time in our reports
filed with the Securities and Exchange Commission. Any
forward-looking statements set forth in this press release speak
only as of the date of this press release. We do not undertake to
update any of these forward-looking statements to reflect events or
circumstances that occur after the date hereof. This press release
and prior releases are available at http://www.keryx.com. The
information found on our website is not incorporated by reference
into this press release and is included for reference purposes
only.
CONTACT: KERYX CONTACT:
Lauren Fischer
Director - Investor Relations
Keryx Biopharmaceuticals, Inc.
Tel: 212.531.5965
E-mail: lfischer@keryx.com
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